NCT00604188 is a Phase 4 clinical trial of Suboxone (SCH 000484) in Opiate Dependence, sponsored by Merck Sharp & Dohme LLC.

Who is sponsoring NCT00604188?

NCT00604188 is sponsored by Merck Sharp & Dohme LLC.

What drugs are being tested in NCT00604188?

Interventions in NCT00604188: Suboxone (SCH 000484), Subutex (SCH 028444).

What condition does NCT00604188 study?

NCT00604188 studies Opiate Dependence, Drug Dependence, Substance Dependence.

Is NCT00604188 still recruiting?

NCT00604188 is currently completed. Last updated 2 July 2017.

Are results published for NCT00604188?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-07-02 · How we verify

NCT00604188

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users (P05042)(COMPLETED)

Completed Phase 4 Results posted Last updated 2 July 2017

What this trial tests

Phase 4 trial testing Suboxone (SCH 000484) in Opiate Dependence in 188 participants. Completed in 10 December 2009.

Timeline

22 February 2008

Primary endpoint
10 December 2009

10 December 2009

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	188
Start date	22 February 2008
Primary completion	10 December 2009
Estimated completion	10 December 2009

Drugs / interventions tested

Suboxone (SCH 000484) — full drug profile →
Subutex (SCH 028444) — full drug profile →

Conditions studied

Opiate Dependence — all drugs for Opiate Dependence →
Drug Dependence — all drugs for Drug Dependence →
Substance Dependence — all drugs for Substance Dependence →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

15 and older, any sex, with Opiate Dependence or Drug Dependence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Responders at Day 3 Primary · 3 days

Responders included the number of participants who received the scheduled dose of Suboxone at the Day 3 study visit. Participants who discontinued the study at Day 3 were considered non-responders. All participants that continued the study received Suboxone tablets on Day 3.

Responders

Group	Value	95% CI
Direct Suboxone Induction	85
Subutex-to-Suboxone Induction	85

Non responders

Group	Value	95% CI
Direct Suboxone Induction	8
Subutex-to-Suboxone Induction	9

Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS) Secondary · 28 days

Number of participants who tested negative on UDS during open-label phase on Day 28. The drugs screened on Day 28 included amphetamines, methamphetamines, cocaine, morphine, methadone, benzodiazepines, and tetrahydrocannabinol. Buprenorphine was only tested at screening and randomization according to protocol, therefore no values for buprenorphine are available for Day 28.

Tetrahydrocannabinol

Group	Value	95% CI
Direct Suboxone Induction	65
Subutex-to-Suboxone Induction	59

Cocaine

Group	Value	95% CI
Direct Suboxone Induction	70
Subutex-to-Suboxone Induction	69

Amphetamines

Group	Value	95% CI
Direct Suboxone Induction	77
Subutex-to-Suboxone Induction	81

Benzodiazepines

Group	Value	95% CI
Direct Suboxone Induction	59
Subutex-to-Suboxone Induction	64

Methamphetamines

Group	Value	95% CI
Direct Suboxone Induction	79
Subutex-to-Suboxone Induction	80

Morphine

Group	Value	95% CI
Direct Suboxone Induction	66
Subutex-to-Suboxone Induction	67

Methadone

Group	Value	95% CI
Direct Suboxone Induction	76
Subutex-to-Suboxone Induction	81

Buprenorphine

Group	Value	95% CI
Direct Suboxone Induction	NA
Subutex-to-Suboxone Induction	NA

Illicit Opioid and Non-opioid Drug Use: Substance Use Inventory (SUI) Secondary · Days 3 to 28

Number of participants with intravenous use of drug as measured by self-reported SUI from Days 3-28. The SUI form consisted of questions addressing the number of days and times a drug was used, and the route of drug use. For suboxone the use of scheduled study medication was not considered illicit use.

Subutex - Non prescription source

Group	Value	95% CI
Direct Suboxone Induction	0
Subutex-to-Suboxone Induction	0

Suboxone - Non prescription source

Group	Value	95% CI
Direct Suboxone Induction	0
Subutex-to-Suboxone Induction	0

Suboxone - Illicit use from study supplies

Group	Value	95% CI
Direct Suboxone Induction	0
Subutex-to-Suboxone Induction	0

Heroin

Group	Value	95% CI
Direct Suboxone Induction	12
Subutex-to-Suboxone Induction	14

Other opioids

Group	Value	95% CI
Direct Suboxone Induction	0
Subutex-to-Suboxone Induction	0

Methadone

Group	Value	95% CI
Direct Suboxone Induction	0
Subutex-to-Suboxone Induction	0

Methamphetamine

Group	Value	95% CI
Direct Suboxone Induction	0
Subutex-to-Suboxone Induction	0

Cocaine

Group	Value	95% CI
Direct Suboxone Induction	2
Subutex-to-Suboxone Induction	4

Self-reported Opioid Withdrawal Symptoms (SOWS) Secondary · Baseline and 28 days

SOWS were 16 items whose intensity was scored on a scale from 0 (not at all) to 4 (extremely) for a maximum possible score of 64. A total score of 0 represented the best outcome and a score of 64 represented the worst outcome. Participants were scored for SOWS at baseline (prior to randomization) and on Day 28. Reported are the scores for Day 28, and the change in scores from baseline to Day 28.

Score on Day 28

Group	Value	95% CI
Direct Suboxone Induction	3.8	± 6.77
Subutex-to-Suboxone Induction	3.4	± 5.95

Change from Baseline to Day 28

Group	Value	95% CI
Direct Suboxone Induction	-23.3	± 14.1
Subutex-to-Suboxone Induction	-21.9	± 13.4

Observer-rated Opioid Withdrawal Symptoms (OOWS) Secondary · Baseline and 28 days

The OOWS were 13 physically observable signs that were present (scored 1) or absent (scored 0). A total score of 0 represented the best outcome and a total score of 13 represented the worst outcome. Participants were scored for OOWS at baseline (prior to randomization) and on Day 28. Reported are the total score for Day 28, and the change in scores from baseline to Day 28.

OOWS Score on Day 28

Group	Value	95% CI
Direct Suboxone Induction	0.6	± 1.36
Subutex-to-Suboxone Induction	0.5	± 0.87

Change from Baseline

Group	Value	95% CI
Direct Suboxone Induction	-5.9	± 3.19
Subutex-to-Suboxone Induction	-5.9	± 3.24

Addiction-related Severity Index (ASI-Lite): A Composite Score to Evaluate Seven Potential Problem Areas: Medical, Employment/Support Status, Alcohol, Drug, Legal, Family/Social, and Psychiatric Secondary · Baseline and 28 days

The ASI-Lite is a standardized, multidimensional, semi-structured, comprehensive interview that estimates addiction-related problem severity profiles in seven domains commonly affected in substance abusers. ASI-lite composite score ranges from 0 (worst outcome) to 1 (best outcome) for each category. Reported here is the change in ASI-Lite from baseline to Day 28. The original drug use accounts for heroin, methadone, other opiates, analgesics, medicine/pills, cocaine, amphetamines, cannabis, hallucinogens, and inhalants. Modified drug use accounts for heroin, methadone, cocaine, and cannabis.

Medical

Group	Value	95% CI
Direct Suboxone Induction	-0.05	± 0.027
Subutex-to-Suboxone Induction	-0.05	± 0.027

Employment

Group	Value	95% CI
Direct Suboxone Induction	-0.04	± 0.034
Subutex-to-Suboxone Induction	-0.02	± 0.033

Employment satisfaction

Group	Value	95% CI
Direct Suboxone Induction	-0.10	± 0.030
Subutex-to-Suboxone Induction	-0.01	± 0.029

Alcohol use

Group	Value	95% CI
Direct Suboxone Induction	-0.03	± 0.017
Subutex-to-Suboxone Induction	-0.01	± 0.017

Drug use (Original)

Group	Value	95% CI
Direct Suboxone Induction	-0.24	± 0.018
Subutex-to-Suboxone Induction	-0.23	± 0.017

Drug use (Modified)

Group	Value	95% CI
Direct Suboxone Induction	-0.36	± 0.021
Subutex-to-Suboxone Induction	-0.34	± 0.021

Legal status

Group	Value	95% CI
Direct Suboxone Induction	-0.09	± 0.026
Subutex-to-Suboxone Induction	-0.08	± 0.025

Family/Social relations

Group	Value	95% CI
Direct Suboxone Induction	-0.10	± 0.040
Subutex-to-Suboxone Induction	-0.10	± 0.041

Compliance Rate Secondary · 28 days

Compliance rate was calculated as the number of days study medication was taken divided by the number of days study medication should have been taken X 100. The number of days study medication should have been taken was equal to the duration of treatment.

Group	Value	95% CI
Direct Suboxone Induction	98.7	± 4.22
Subutex-to-Suboxone Induction	98.4	± 6.25

Responders at Day 28 Secondary · 28 days

Responders were the number of participants in each group who received the scheduled 8- to 24-mg dose of Suboxone at study visit day. A participant who discontinued from the study was treated as a non-responder at the timepoint after the participant discontinued.

Responder

Group	Value	95% CI
Direct Suboxone Induction	46
Subutex-to-Suboxone Induction	55

Non-responder

Group	Value	95% CI
Direct Suboxone Induction	47
Subutex-to-Suboxone Induction	39

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Direct Suboxone Induction

Serious: 1/93 (1%)

Deaths: —

Subutex-to-Suboxone Induction

Serious: 3/94 (3%)

Deaths: —

Serious adverse events (6 terms)

Reaction	System	Direct Suboxone Induction	Subutex-to-Suboxone Induct…
ABSCESS LIMB	Infections and infestations	—	—
EPILEPSY	Nervous system disorders	—	—
DEPRESSION	Psychiatric disorders	—	—
DRUG DEPENDENCE	Psychiatric disorders	—	—
PERSONALITY DISORDER	Psychiatric disorders	—	—
RASH	Skin and subcutaneous tissue disorders	—	—

Other adverse events (18 terms — click to expand)

Reaction	System	Direct Suboxone Induction	Subutex-to-Suboxone Induct…
INSOMNIA	Psychiatric disorders	—	—
HYPERHIDROSIS	Skin and subcutaneous tissue disorders	—	—
ANXIETY	Psychiatric disorders	—	—
DRUG DEPENDENCE	Psychiatric disorders	—	—
VOMITING	Gastrointestinal disorders	—	—
NAUSEA	Gastrointestinal disorders	—	—
MYALGIA	Musculoskeletal and connective tissue disorders	—	—
FEELING COLD	General disorders	—	—
SOMNOLENCE	Nervous system disorders	—	—
HEADACHE	Nervous system disorders	—	—
ASTHENIA	General disorders	—	—
RESTLESSNESS	Psychiatric disorders	—	—
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	—	—
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	—	—
TOOTHACHE	Gastrointestinal disorders	—	—
CHILLS	General disorders	—	—
ABDOMINAL PAIN	Gastrointestinal disorders	—	—
HOT FLUSH	Vascular disorders	—	—

Most-reported serious reactions: ABSCESS LIMB, EPILEPSY, DEPRESSION, DRUG DEPENDENCE, PERSONALITY DISORDER, RASH.

Data from ClinicalTrials.gov NCT00604188 adverse events section.

Sponsor's own description

The purpose of this study is to assess the acceptability and safety of Suboxone in heroin users as a replacement therapy for opioid dependency by comparing the clinical response of participants who are inducted directly onto Suboxone with that of participants who are inducted first to Subutex and then transferred to Suboxone.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00604188 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 2 July 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00604188.

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